PMA P060008S046

Device

TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM (MONORAIL AND OVER-THE-WIRE)

Applicant

Boston Scientific Corp

PMA number

P060008

Supplement

S046

Product code

NIQ

Decision date

2012-02-22

Generic name

Coronary drug-eluting stent

Approval order statement

APPROVAL TO EXPAND THE LABELED INDICATIONS FOR THE TAXUS LIBERTÈ PACLITAXEL-ELUTING CORONARY STENT SYSTEM. THE TAXUS® LIBERTÈ® PACLITAXEL-ELUTING CORONARY STENT SYSTEM (MONORAIL AND OVER-THE-WIRE SYSTEMS) IS INDICATED FOR IMPROVING LUMINAL DIAMETER: 1) FOR THE TREATMENT OF DE NOVO LESIONS IN NATIVE CORONARY ARTERIES 2.75 MM TO 4.00 MM IN DIAMETER IN LESIONS <= 34 MM IN LENGTH; 2) FOR THE TREATMENT OF DE NOVO LESIONS IN NATIVE CORONARY ARTERIES 2.25 MM TO 2.50 MM IN DIAMETER IN LESIONS <= 28 MM IN LENGTH; OR 3) IN PATIENTS UNDERGOING PRIMARY ANGIOPLASTY TO TREAT ACUTE ST-SEGMENT ELEVATION MYOCARDIAL INFARCTION, TRUE POSTERIOR MYOCARDIAL INFARCTION, OR PRESUMED NEW LEFT BUNDLE BRANCH BLOCK WITH SYMPTOMS OF ACUTE MYOCARDIAL INFARCTION LASTING > 20 MINUTES AND < 12 HOURS IN DURATION.